LupusFRESH COLANCT02857452
Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire
An observational study of Lupus, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life. The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus
- What is being tested?
- SLA Questionnaire and Lupus Qol Questionnaire
- How many people
- 162 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous
Who may be able to join
- Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous.
- Patients able to understand written and spoken French.
- Patients who have been informed about the research
Who cannot join
- Severe mental retardation.
- Any impairment of ability to understand making self-evaluation impossible.
- Age < 18 years.
- Age > 75 years.
Trial locations and contacts
1 site in 1 country.
About this study
The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life.
The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients.
This tool, validated in a British population, has never been validated in French.
- Conditions
- Lupus
- Being tested
- SLA Questionnaire, Lupus Qol Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLA QuestionnaireOther
Lupus Qol QuestionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| Lupus | Not described Receives: Other: SLA Questionnaire; Other: Lupus Qol Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ)
Measured: Evolution of answers between D0, D15, M3 and M6
Secondary outcomes (1)
Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire
Measured: Evolution of answers between D0, D15, M3 and M6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJan 2009
- Primary completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LupusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857452
- Sponsor's protocol ID
- DEVILLIERS 189 HORS AOI 2008
- Acronym
- FRESH COLA
- Status last verified
- Jul 2016
- First submitted
- 2 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire
- ClinicalTrials.gov ID
- NCT02857452
- Acronym / sponsor ID
- FRESH COLA / DEVILLIERS 189 HORS AOI 2008
- Conditions
- Lupus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2010 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life.
The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients.
This tool, validated in a British population, has never been validated in French.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupus | – | Other: SLA Questionnaire, Other: Lupus Qol Questionnaire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous
Key inclusion criteria (3 listed)
- Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous.
- Patients able to understand written and spoken French.
- Patients who have been informed about the research
Key exclusion criteria (4 listed)
- Severe mental retardation.
- Any impairment of ability to understand making self-evaluation impossible.
- Age < 18 years.
- Age > 75 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLA Questionnaire | Other | Lupus |
| Lupus Qol Questionnaire | Other | Lupus |
Primary outcome
Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ)
Time frame: Evolution of answers between D0, D15, M3 and M6
1 secondary outcome
Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire
Time frame: Evolution of answers between D0, D15, M3 and M6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ) (time frame: Evolution of answers between D0, D15, M3 and M6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.